1. Managing a Research Project
Alasdair MacLullich
MRC Clinician Scientist Fellow
Hon Consultant in Geriatric Medicine

3. Overview Projects vs clinical work (Question, protocol)
Detailed protocol development
Setting up
Getting started
Running the project
Concluding the project 3

4. Projects vs clinical work
What is a project?
Unique
Temporary
Specific outcomes
Has a timeline 4

5. Projects vs clinical work
Project Management
Formal approach
Specialist area
Anyone doing a project can benefit from using some kind of formal approach
Courses/books are useful 5

6. Question(s), protocol Question Protocol
Clear, important, answerable, planned analyses
Protocol
At early stages often an overview
Will usually need more detailed development 6

7. Detailed protocol development
Moves from outline to detailed planning
Step-by-step analysis
Flowchart is essential
Allows identification of possible hitches early
Allows identification of steps that need to be taken early
Detail on conduct of project is required for ethics and R&D 7

8. Setting up 8

9. Setting up Documentation Protocol
Information sheets and consent forms for participants
Information sheets for clinical staff (eg. GP letters)
Data recording forms 9

10. Setting up Ethics Needs care and time
Essential to know timelines: check corec.org.uk
Mostly straightforward if preparation done
NB documentation required for study anyway
R&D
Occurs in parallel with ethics, takes a few weeks 10

11. Setting up Laboratory work Licensing for animal work
Health and safety – labs have comprehensive procedures 11

12. Setting up Training Self or others Formal approach is helpful
Develop paperwork and practise
Check that quality of assessments are high enough
Legal requirements (eg. hon contracts, health and safety) 12

13. Setting up
Other team members
Supervisor
Statistician
Collaborators 13

14. Setting up Ward staff Mostly very helpful
But busy with core work and protective of patients
Courteous and timely communication is important
Inform senior staff (charge nurses, consultants, managers) in advance
Need clear story of what you are doing
Consider carrying letter of introduction
ID badges for research staff 14

15. Setting up Setting up the database Excel adequate for small projects
Better to use stats program or data entry program for bigger/complex projects
The more categories the better
Naming variables
Think about the analysis
Who is going to be entering the data? 15

16. Getting started 16

17. Getting started Walk-through With flowchart, check:
All documents in place
All relevant people aware
Do virtual walk-through, preferably with team
Do actual walk-through on site(s) of project
Set a start date
Send this to all collaborators 17

18. Running the project Start slowly Keep a ‘lab book’ record of progress
eg. comments from patients & staff
Seek regular feedback from any staff
Maintain overview (vs day to day work)
Regular communication with collaborators
Data entry: keep up with this, check accuracy 18

19. What if things go wrong? 19

20. Running the project What if things go wrong? Eg. Recruitment is poor
Some instruments (eg. rating scales) not working
Assessments taking too long
Findings are far from what is expected
Assessments clash with ward work 20

21. Running the project What if things go wrong?
Allow some time to pass (need a few goes to be sure)
Discuss with supervisor
Consider altering the protocol, eg. sites or recruitment, exclusion criteria, no. of assessments
Most protocol changes require ethics/R&D approval: takes 3-4 weeks
Always have an overview of the whole project and where it is going 21

22. Concluding the project
Set a finish date
Make a plan for writing-up
Thank all people involved
Communicate with collaborators, etc.
Report to ethics
Disseminate! 22

23. Overview Projects vs clinical work The overall project plan
(Question, protocol)
Detailed protocol development
Setting up
Getting started
Running the project
Concluding the project 23

24. Resources www.bgs.org.uk UoE Geriatric Medicine Unit
UoE – statisticians, collaborators
UoE/NHS courses
Wellcome Trust Clinical Research Facility 24